Updated results of the SPRINT trial confirm previous findings
Final Report of a Trial of Intensive versus Standard Blood-Pressure Control
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Introduction and methods
Primary results of the Systolic Blood Pressure Intervention Trial (SPRINT) trial were previously reported using data through August 2015 when the trial was stopped due to benefit in the intensive treatment group . In the SPRINT trial the effect of a systolic blood pressure (SBP) target <120 mmHg on clinical outcomes was compared to that of SBP target <140 mmHg.
Data have been collected during an observational postintervention period. An updated analysis of all data through August 2015, as well as an analysis of data through July 2016 has been reported.
In the SPRINT trial, 9361 individuals ≥50 years with SBP 130-180 mmHg with or without antihypertensive drugs plus ≥indicator of CV risk were enrolled. Patients were randomized in 1:1 ratio to SBP goal <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). Clinical, laboratory and adverse events data were collected at quarterly follow-up visits. BP was measured by trained staff with an automated device while participants were seated. The observational postintervention period started after August 2015 when patients’ management returned to normal. Close-out visits were from December 2015 through July 2016.
Primary outcome was a composite of Mi, ACS not resulting in MI, stroke, acute decompensated HF or death from CV causes. In those with CKD at baseline, the main composite renal outcome was end-stage renal disease or a ≥50% decline in eGFR from baseline. In those without CKD, the renal outcomes was ≥30% decline in eGFR to <60 mL/1.73m2. Median follow-up of the study with complete outcome adjudication of all events through August 2015 was 3.33 years. Median follow-up through July 2016 was 3.88 years.
- In the current analysis with all events through August 2015, rate of the primary outcome was 1.77 per year in the intensive-treatment group and 2.40% per year in the standard-treatment group (HR 0.73, 95%CI: 0.63-0.86, P<0.001), similar to the previous finding (HR 0.75).
- Exclusion of nonfatal HF in the primary outcome did not change the results (HR 0.75).
- In the intensive-treatment group, all-cause mortality was 1.06% per year and 1.41% in the standard-treatment group (HR 0.75, 95%CI: 0.61-0.92, P=0.006), similar to previous findings (HR 0.73).
- Rates of individual endpoints of MI, HF, and death from CV causes were lower in the intensive-treatment group than in the standard-treatment group.
- There was no significant between-group difference in the renal composite endpoint between the two groups in those with CKD at baseline.
- In those who did not have CKD at baseline, the renal endpoint was more common in the intensive-treatment group than in the standard-treatment group (HR 3.67, 95%CI:2.62-5.26, p<0.001).
- There was no differential effect of treatment group on the primary outcome or all-cause mortality between the intervention and post-intervention periods, but there were differences for acute decompensated HF and the renal outcome between the two periods (higher rate of acute decompensated HF in the intensive-treatment group in the post-intervention period and lower rate of the renal outcome in the intensive-treatment group in the post-intervention period).
- When intervention and postintervention results were combined, the primary outcome and death remained significantly lower in the intensive-treatment group than in the standard-treatment group (HR 0.76, 95%CI: 0.65-0.88, P<0.001 and HR 0.79, 95%CI: 0.66-0.94, P=0.009, respectively). Also, rates of MI, and death from CV causes remained lower in the intensive-treatment group than in the standard-treatment group. Rates of HF events were not different between the two groups.
- In the intervention period or the intervention and postintervention period combined, hypotension, electrolyte abnormalities and acute kidney injury or renal failure occurred more often in the intensive-treatment group than in the standard-treatment group.
Updated results from the SPRINT trial showed that intensive-treatment regime with SBP target <120 mmHg resulted in reduction of the primary composite outcome, the primary outcome minus HF events, the components of the primary outcome, and all-cause mortality when compared to standard treatment regime with target goal <140 mmHg in patients with increased CV risk. There were more adverse events in the intensive-treatment group though, and in the post-trial observational period, there was more HF in this group.
What do you think the cutoff value for normal systolic blood pressure should be?
- 120 mmHg
- 130 mmHg